Commission Implementing Regulation (EU) 2017/2274 of 8 December 2017 concerning the authorisation of a new use of a preparation of 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) as a feed additive for fish (holder of authorisation Huvepharma EOOD) (Text with EEA relevance. )

• CELEX: Implementing Regulation (EU) 2017/2274
• Articles: 3

Article 1

The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Schedules & Appendices

ANNEX

ANNEX

Identification number of the additive

Name of the holder of authorisation

Additive

Composition, chemical formula, description, analytical method

Species or category of animal

Maximum age

Minimum content

Maximum content

Other provisions

End of period of authorisation

Units of activity/kg of complete feedingstuff with a moisture content of 12 %

Category of zootechnical additives. Functional group: digestibility enhancers.

4a16

Huvepharma EOOD

6-phytase

(EC 3.1.3.26)

Additive composition

Preparation 6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036) with a minimum activity of:

4 000 OTU  ( 1 ) /g in solid form

8 000 OTU/g in liquid form

Characterisation of the active substance

6-phytase (EC 3.1.3.26) produced by Komagataella pastoris (DSM 23036)

Analytical method

( 2 )

For quantification of 6-phytase in feed:

Colorimetric method based on the quantification of the inorganic phosphate released by the enzyme from the sodium phytate.

Fish

—

500 OTU

—

1.

In the directions for use of the additive and premixture, the storage conditions and stability to heat treatment shall be indicated.

2.

For use in feed containing more than 0,23 % phytin-bound phosphorus.

3.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use. Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with protective equipment, including breathing and skin protections.

29.12.2027

( 1 )   1 OTU is the amount of enzyme that catalyses the release of 1 micromole of inorganic phosphate per minute from 5,1 mM sodium phytate in pH 5,5 citrate buffer at 37 °C, measured as the blue P-molybdate complex colour at 820 nm.

( 2 )   Details of the analytical methods are available at the following address of the Reference Laboratory: http://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.